Tissue anchors, systems and methods, and devices

ABSTRACT

Systems, devices and methods for securing tissue including the annulus of a mitral valve. The systems, devices and methods may employ catheter based techniques and devices to plicate tissue and perform an annuloplasty.

CROSS-REFERENCE TO RELATED APPLICATION

The present application is a divisional of U.S. patent application Ser.No. 15/144,182, filed May 2, 2016, which is a divisional of U.S. patentapplication Ser. No. 14/010,950, filed Aug. 27, 2013, now U.S. Pat. No.9,358,111, issued Jun. 7, 2016, which is a continuation of U.S. patentapplication Ser. No. 11/685,240, filed Mar. 13, 2007, each of which isincorporated by reference as if expressly set forth in their respectiveentirety herein.

TECHNICAL FIELD

The present invention relates generally to tissue fastening and, moreparticularly, tissue fastening performed in a minimally invasive andpercutaneous manner.

BACKGROUND

Referring initially to FIGS. 1-4 solely for purposes of understandingthe anatomy of a heart 10, and specifically the left side of the heart10, the left atrium (LA) 12 and left ventricle (LV) 14 are shown. Anaorta 16 receives oxygenated blood from left ventricle 14 through anaortic valve 18, which serves to prevent regurgitation of blood backinto left ventricle 14. A mitral valve 20 is positioned between leftatrium 12 and left ventricle 14, and allows one-way flow of theoxygenated blood from the left atrium 12 to the left ventricle 14.

Mitral valve 20, which will be described below in more detail, includesan anterior leaflet 22 and a posterior leaflet 24 that are coupled tocordae tendonae 26, 28 (FIG. 4 ). Cordea tendonea 26, 28 serve as“tension members” that prevent the leaflets 22, 24 of mitral valve 20from moving past their closing point and prolapsing back into the leftatrium 12. When left ventricle 14 contracts during systole, cordaetendonae 26, 28 limit the upward motion (toward the left atrium) of theanterior and posterior leaflets 22, 24 past the point at which theanterior and posterior leaflets 22, 24 meet and seal to prevent backflowfrom the left ventricle 14 to the left atrium 12 (“mitral regurgitation”or “mitral insufficiency”). Cordae tendonae 26, 28 arise from a columnaecarnae or, more specifically, a musculi papillares (papillary muscles)of the columna carnae. In various figures herein, some anatomicalfeatures have been deleted solely for clarity.

Anterior leaflet 22 and posterior leaflet 24 of the mitral valve 20 aregenerally thin, flexible membranes. When mitral valve 20 is closed,anterior leaflet 22 and posterior leaflet 24 are generally aligned andcontact one another along a “line of coaptation” several millimetersback from their free edges, to create a seal that prevents mitralregurgitation. Alternatively, when mitral valve 20 is opened, bloodflows downwardly through an opening created between anterior leaflet 22and posterior leaflet 24 into left ventricle 14.

Many problems relating to the mitral valve may occur and may cause manytypes of ailments. Such problems include, but are not limited to, mitralregurgitation. Mitral regurgitation, or leakage, is the backflow ofblood from left ventricle 14 into the left atrium 12 due to an imperfectclosure of mitral valve 20. That is, leakage often occurs when theanterior and posterior leaflets 22, 24 do not seal against each other,resulting in a gap between anterior leaflet 22 and posterior leaflet 24when the leaflets are supposed to be fully coapted during systole.

In general, a relatively significant systolic gap may exist betweenanterior leaflet 22 and posterior leaflet 24 for a variety of differentreasons. For example, a gap may exist due to congenital malformations,because of ischemic disease, or because the heart 10 has been damaged bya previous heart attack. Such a gap may also be created when congestiveheart failure, e.g., cardiomyopathy, or some other type of distresswhich causes a heart 10 to be enlarged. Enlargement of the heart 10 canresult in dilation (stretching) of the mitral annulus. This enlargementis usually limited to the posterior valve annulus and is associated withthe posterior leaflet 24, because the anterior annulus is a relativelyrigid fibrous structure. When the posterior annulus enlarges, it causesthe posterior leaflet 24 to move away from the anterior leaflet 22,causing a gap during systole because the two leaflets no longer formproper coaptation. This results in leakage of blood through the valve20, or regurgitation.

Blood leakage through mitral valve 20 generally causes a heart 10 tooperate less efficiently, as the heart 10 pumps blood both out to thebody via the aorta 16, and also back (in the form of mitralregurgitation) into the left atrium 12. Leakage through mitral valve 20,or general mitral insufficiency, is thus often considered to be aprecursor to congestive heart failure (CHF) or a cause of progressiveworsening of heart failure. There are generally different levels ofsymptoms associated with heart failure. These levels are classified bythe New York Heart Association (NYHA) functional classification system.The levels range from a Class 1 level which is associated with anasymptomatic patient who has substantially no physical limitations to aClass 4 level which is associated with a patient who is unable to carryout any physical activity without discomfort and has symptoms of cardiacinsufficiency even at rest. In general, correcting or reducing thedegree of mitral valve leakage may be successful in allowing the NYHAclassification grade of a patient to be reduced. For instance, a patientwith a Class 4 classification may have his classification reduced toClass 3 or Class 2 and, hence, be relatively comfortable at rest or evenduring mild physical exertion. By eliminating the flow of bloodbackwards into the left atrium 12, therapies that reduce mitralinsufficiency reduce the workload of the heart 10 and may prevent orslow the degradation of heart function and congestive heart failuresymptoms that is common when a significant degree of mitralinsufficiency remains uncorrected.

Treatments used to correct for mitral valve leakage or, more generally,CHF, are typically highly invasive, open-heart surgical procedures. Inextreme cases, this may include implantation of a ventricular assistdevice such as an artificial heart in a patient with a failing heart.The implantation of a ventricular assist device is often expensive, anda patient with a ventricular assist device must be placed on extendedanti-coagulant therapy. Anti-coagulant therapy reduces the risk of bloodclot formation for example, within the ventricular assist device.Reducing the risks of blood clots associated with the ventricular assistdevice is desirable, but anti-coagulant therapies may increase the riskof uncontrollable bleeding in a patient, e.g., as a result of a fall.

Rather than implanting a ventricular assist device, bi-ventricularpacing devices similar to pacemakers may be implanted in some cases,e.g., cases in which a heart beats inefficiently in a particularasynchronous manner. While the implantation of a bi-ventricular pacingdevice may be effective, not all heart patients are suitable forreceiving a bi-ventricular pacing device. Further, the implantation of abi-ventricular pacing device is expensive, and is generally noteffective in significantly reducing or eliminating the degree of mitralregurgitation.

Open-heart surgical procedures that are intended to correct for mitralvalve leakage, specifically, can involve the implantation of areplacement valve. Valves from animals, e.g., pigs, may be used toreplace a mitral valve 20 in a human. While a pig valve may relativelysuccessfully replace a mitral valve, such replacement valves generallywear out, thereby requiring additional open surgery at a later date.Mechanical valves, which are less likely to wear out, may also be usedto replace a leaking mitral valve. However, when a mechanical valve isimplanted, there is an increased risk of thromboembolism, and a patientis generally required to undergo extended anti-coagulant therapies.

A less invasive surgical procedure involves heart bypass surgeryassociated with a port access procedure. For a port access procedure,the heart may be accessed by cutting between ribs or sometimes removingparts of one or more ribs, as opposed to dividing the sternum to openthe entire chest of a patient.

One open-heart surgical procedure that is particularly successful incorrecting for mitral valve leakage and, in addition, mitralregurgitation, is an annuloplasty procedure. During an annuloplastyprocedure, a medical device such as an annuloplasty ring may beimplanted surgically on the left atrial side of mitral annulus (i.e.,generally the attachment location of the base of the mitral valve to theheart). The device reduces a dilated mitral valve annulus to arelatively normal size and, specifically, moves the posterior leafletcloser to the anterior leaflet to aid anterior-posterior leafletcoaptation and thus improve the quality of mitral valve closure duringsystole. Annuloplasty rings are often shaped substantially like theletter “D” to correspond to the natural shape of the mitral annulus asviewed from above. Typically, the rings are formed from a rod or tube ofbiocompatible material, e.g., plastic, that has a DACRON mesh covering.

In order for an annuloplasty ring to be implanted, a surgeon surgicallyattaches the annuloplasty ring to the mitral valve on the atrial side ofthe mitral valve. Conventional methods for installing a ring requireopen-heart surgery which involves opening a patient's sternum andplacing the patient on a heart bypass machine. The annuloplasty ring issewn on a top portion of the mitral valve. In sewing the annuloplastyring onto the mitral valve, a surgeon generally sews the straight sideof the “D” to the fibrous tissue located at the junction between theposterior wall of the aorta and the base of the anterior mitral valveleaflet. As the curved part of the ring is sewn to the posterior aspectof the annulus, the surgeon alternately acquires a relatively largeramount of tissue from the mitral annulus, e.g., a one-eighth inch biteof tissue, using a needle and thread, compared to a relatively smallerbite taken of the fabric covering of the annuloplasty ring. Once thethread has loosely coupled the annuloplasty ring to the mitral valveannulus tissue, the annuloplasty ring is slid into contact with themitral annulus. The tissue of the posterior mitral annulus that waspreviously stretched out, e.g., due to an enlarged heart, is effectivelyreduced in circumference and pulled forwards towards the anterior mitralleaflet by the tension applied by annuloplasty ring with the suture orthread. As a result, a gap between anterior leaflet 22 and posteriorleaflet 24 during ventricular contraction or systole may be reduced andeven substantially closed off in many cases thereby significantlyreducing or even eliminating mitral insufficiency. After the mitralvalve 20 is shaped by the ring, the anterior and posterior leaflets 22,24 will reform typically by pulling the posterior leaflet 24 forward toproperly meet the anterior leaflet 22 and create a new contact line thatwill enable mitral valve 20 to appear and to function properly.

Although a patient that receives an annuloplasty ring may be subjectedto anti-coagulant therapies, the therapies are not extensive, as apatient is only subjected to the therapies for a matter of weeks, e.g.,until tissue grows over the annuloplasty ring.

Another type of procedure that is generally effective in reducing mitralvalve leakage associated with prolapse of the valve leaflets involvesplacing a single edge-to-edge suture in the mitral valve 20 that apposesthe mid-portions of anterior and posterior leaflets 22, 24. For example,in an Alfieri stitch or a bow-tie repair procedure, an edge-to-edgestitch is made at approximately the center of the gap between ananterior leaflet 22 and a posterior leaflet 24 of a mitral valve 20.Once the stitch is in place between the anterior and posterior leaflets22, 24, it is pulled in to form a suture which holds anterior leaflet 22against posterior leaflet 24.

Another surgical procedure that reduces mitral valve leakage involvesplacing sutures along a mitral valve annulus around the posteriorleaflet 24. These sutures may be formed as a double track, e.g., in two“rows” from a single strand of suture material. The sutures are tied offat approximately a central point (P2) of posterior leaflet 24. Pledgetsare often positioned under selected sutures to prevent the sutures fromtearing through annulus 40. When the sutures are tightened and tied off,the circumference of the annulus 40 may effectively be reduced to adesired size such that the size of a systolic gap between posteriorleaflet 24 and an anterior leaflet 22 may be reduced.

While invasive surgical procedures have proven to be effective in thetreatment of mitral valve leakage, invasive surgical procedures oftenhave significant drawbacks. Any time a patient undergoes open-heartsurgery, there is a risk of infection. Opening the sternum and using acardiopulmonary bypass machine has also been shown to result in asignificant incidence of both short and long term neurological deficits.Further, given the complexity of open-heart surgery, and the significantassociated recovery time, people that are not greatly inconvenienced byCHF symptoms, e.g., people at a Class 1 classification, may choose notto have corrective surgery. In addition, people that need open heartsurgery the most, e.g., people at a Class 4 classification, may eitherbe too frail or too weak to undergo the surgery. Hence, many people thatmay benefit from a surgically repaired mitral valve may not undergosurgery.

In another method, a cinching device is placed within the coronary sinus(CS) using a catheter system, with distal, mid, and proximal anchorswithin the lumen of the CS to allow plication of the annulus 40 via theCS. In practice, these anchors are cinched together and the distancebetween them is shortened by pulling a flexible tensile member such as acable or suture with the intent being to shorten the valve annulus 40and pull the posterior leaflet 24 closer to the anterior leaflet 22 in amanner similar to an annuloplasty procedure. Unfortunately, since thetissue that forms the CS is relatively delicate, the anchors are proneto tear the tissue during the cinching procedure. In addition, theeffect on the mitral annulus may be reduced when the CS of a particularpatient is not directly aligned with the mitral annulus. Other minimallyinvasive techniques have been proposed but have various drawbacksrelated to such factors as effectiveness and/or accuracy ofcatheter-based implementation.

SUMMARY

In one embodiment, a system is provided for accurately introducing anelement into tissue proximate (i.e., either at or close to) the mitralvalve annulus of the heart of a patient. The element may be any desiredstructure suitable for the intended purpose. In one more specificembodiment, for example, the element may advantageously comprise a guidewire. The system includes a first catheter device having a first distalend portion capable of being introduced through the vascular system ofthe patient and into the coronary sinus proximate the mitral valveannulus. The first catheter device includes first, second and thirdspaced apart radiopaque markers at the first distal end portion. Thesystem further includes a second catheter device having a second distalend portion capable of being introduced through the vascular system ofthe patient and into the left ventricle of the heart proximate themitral valve annulus. The second catheter device includes a fourthradiopaque marker at the second distal end portion and a lumen fordelivering an element from the second distal end portion. The fourthradiopaque marker may be aligned with reference to at least one of thefirst, second or third radiopaque markers to deliver the element intothe mitral valve tissue. In one exemplary embodiment, for example, thefourth radiopaque marker is aligned with the first radiopaque marker ofthe first catheter device generally at location P2 of the posteriormitral annulus. The first, second and third radiopaque markers may bespaced apart to correspond to locations P1, P2 and P3 of the posteriormitral valve annulus.

A method is also provided for accurately introducing an element intotissue proximate the mitral valve annulus using a first catheter devicehaving a first distal end portion with a first radiopaque marker and asecond catheter device having a second distal end portion with a lumen.The method comprises introducing the first distal end portion of thefirst catheter device through the vascular system of the patient andinto the coronary sinus proximate the mitral valve annulus. The firstradiopaque marker is positioned at a desired location in the coronarysinus proximate the mitral valve annulus. The second distal end portionof the second catheter device is introduced through the vascular systemof the patient and into the heart proximate the mitral valve annulus.The second distal end portion is positioned in a desired orientationrelative to the first radiopaque marker. The element is then deliveredthrough the lumen into tissue proximate the mitral valve annulus withthe second distal end portion in the desired orientation.

The method of accurately introducing the element into tissue proximatethe mitral valve annulus may further comprise delivering a first guidewire through the mitral valve annulus and into the left atrium of theheart from the left ventricle of the heart. The method may furthercomprise guiding a second element over the first guide wire to aposition proximate the mitral valve annulus and the second element mayfurther comprise a third catheter device. A second guide wire may bedelivered from the third catheter device through the mitral valveannulus and into the left atrium of the heart from the left ventricle ofthe heart. The method may further comprise using the first and secondguide wires to deliver first and second anchors, respectively, into themitral valve annulus, shortening the distance between the first andsecond anchors, and locking the first and second anchors with respect toeach other. This may, for example, form plicated annulus tissue helpfulfor reducing regurgitation through the mitral valve. A third guide wiremay be delivered from the third catheter device through the mitral valveannulus and into the left atrium of the heart from the left ventricle ofthe heart. This third guide wire may be used to deliver a third anchorinto the mitral valve annulus and the distance between at least two ofthe first, second or third anchors may be shortened and then at leastthese two anchors may be locked with respect to each other. In anillustrative embodiment, all three anchors are locked with respect toeach other with the tissue plicated between each of the adjacentanchors. The first distal end portion may further comprise twoadditional radiopaque markers spaced apart on opposite sides of thefirst radiopaque marker. In this case, the method may further comprisepositioning the first radiopaque marker at a location in the coronarysinus proximate location P2 of the mitral valve annulus, and positioningthe two additional radiopaque markers in the coronary sinus respectivelymore proximate to locations P1 and P3 of the mitral valve annulus. Asfurther options, the second distal end portion may further include asecond radiopaque marker and positioning the second distal end mayfurther comprise positioning the second radiopaque marker in a desiredorientation relative to the first radiopaque marker. The firstradiopaque marker may have a predetermined cross sectional shape (e.g.,circular) when viewed directly along the longitudinal axis of the firstcatheter device. In association with this feature, the method mayfurther comprise viewing the first radiopaque marker directly along thelongitudinal axis of the first catheter device while positioning thesecond distal end portion in the desired orientation.

In another illustrative embodiment, a catheter device is provided andcapable of being directed through the vascular system of a patient anddelivering first and second elements into tissue. Again, these elementsmay be any structure suited for the intended purpose. The catheterdevice comprises first, second and third catheter members respectivelyincluding first, second and third lumens. A first connecting member iscoupled between the first and second catheter members and a secondconnecting member coupled between the first and third catheter members.The second and third catheter members are laterally movable in generallyopposite directions relative to the first catheter member betweencollapsed positions suitable for delivery of the first, second and thirdcatheter members through the vascular system and expanded positions inwhich the second and third catheter members are at laterally spacedapart positions relative to the first catheter member for delivering thefirst and second elements into the tissue through the second and thirdlumens.

The catheter device may further comprise a third connecting membercoupled between the first and second catheter members and a fourthconnecting member coupled between the first and third catheter members.The first, second, third and fourth connecting members may furthercomprise bars pivotally coupled between the first, second and thirdcatheter members. The device may further comprise an outer cathetermember or sheath having a fourth lumen with the fourth lumen receivingthe first, second and third catheter members. In this embodiment, thefirst, second and third catheter members may therefore be a triple lumencatheter received within and extendable from the distal end of an outersheath. The second and third catheter members may be movable in alengthwise direction relative to the first catheter member as the secondand third catheter members move laterally to the expanded positions.

The catheter device including the triple lumen catheter, or first,second and third catheter members, may further comprise first, secondand third guide wires respectively received in the first, second andthird lumens. For example, the first guide wire may be used as aninitial guide for delivery of the catheter device to a surgical site,such as within the left ventricle of the heart, and the second and thirdguide wires may be extendable from the device into tissue, such asmitral valve annulus tissue. The first, second and third guide wires mayfurther comprise radiofrequency (RF) energy delivery wires capable ofapplying radiofrequency energy to assist with penetrating the tissue.

In another embodiment, a method is provided for delivering respectiveelements into spaced apart locations along an annulus of a mitral valveusing a catheter device including first, second and third cathetermembers that respectively include first, second and third lumens. Themethod comprises directing a first guide wire through the vascularsystem and into the heart of a patient. The first, second and thirdcatheter members are introduced through the vascular system and into theheart of the patient with the first guide wire received in the firstlumen and with the first, second and third catheter members are in acollapsed state relative to one another. Distal end portions of thefirst, second and third catheter members are positioned proximate theannulus. The distal end portions of the second and third cathetermembers are expanded laterally away from the first catheter member. Therespective elements are then delivered respectively into tissueproximate the annulus through the second and third lumens.

The method of delivering respective elements into spaced apart locationsalong the annulus may further comprise delivering second and third guidewires respectively through the second and third lumens. The method mayfurther comprise applying radiofrequency energy with distal tip portionsof the second and third guide wires to assist with penetrating throughthe tissue. The distal end portions of the first, second and third guidewires may be extended into the left atrium of the heart. The method maythen further comprise delivering first, second and third anchors intothe tissue using the first, second and third guide wires as guides tothe spaced apart locations. The first, second and third anchors may beconnected to the tissue. Distances between two or more of the anchorsmay be shortened and locked in position as generally described above.Respective first, second and third flexible tensile member portions maybe coupled to the first, second and third anchors and locking the first,second and third anchors may further comprise locking at least two ofthe first, second or third flexible tensile member portions together.The flexible tensile member portions may be comprised of any suitablematerial having requisite strength, flexibility and biocompatibility.For this purpose, for example, any suitable suture material, which maybe portions of the same suture material, or discrete and separate suturethreads having respective free ends, may be used. The first, second andthird anchors may be respectively secured to the first, second and thirdflexible tensile members to form first, second and third anchorassemblies. These anchor assemblies may be delivered to the spaced apartlocations via at least one anchor delivery catheter. In an illustrativeembodiment, these anchor assemblies are individually delivered to theleft ventricle via individual, separate anchor delivery catheters.

In another embodiment, a tissue anchor is provided generally comprisinga flexible tensile member and a plurality of discrete, flat flexibleanchor elements coupled for movement along the flexible tensile memberto form one illustrative embodiment of an anchor assembly. The flexibletensile member and at least one of the plurality of discrete, flatflexible anchor elements are capable of being inserted through tissueand of moving between an elongate configuration and a shortenedconfiguration suitable for anchoring the assembly against at least oneside of the tissue. This anchor assembly includes a proximal endportion, a distal end portion, and a compressible intermediate portionbetween the proximal and distal end portions. The compressibleintermediate portion is compressible in that it may be shortened duringan anchoring process. For example, it may comprise multiple anchorelements itself, or more simply a space between proximal and distalanchor elements connected by the flexible tensile member. The anchorelements can slide relative to the flexible tensile member and theflexible tensile member is capable of being pulled to cause the anchorelements to move relative to the flexible tensile member from theelongate configuration to the shortened configuration.

In this anchor assembly embodiment, the anchor elements may be formedfrom any suitable biocompatible material. For example, the material maybe selected from at least one of natural fibers, synthetic fibers,polymers, metals or any combinations thereof (i.e., combinations withone another and/or with other materials). In one embodiment, the anchorelements are formed of material that promotes tissue ingrowth such thatafter implantation, the anchor assembly will be essentially covered bynatural tissue of the patient. The flexible tensile member may comprisea suture having a suitable lock member, such as a simple slip knot forallowing the proximal end of the flexible tensile member to be pulledcausing movement of the slip knot distally and resulting in compressionor relative movement of two or more anchor elements toward each other.The flexible tensile member may extend through each of the anchorelements at multiple locations and one or more of the anchor elementsand/or the flexible tensile member, or both, may have at least oneradiopaque marker to allow visualization under a suitable viewing devicesuch as a fluoroscope during and/or after the anchor installationprocedure. In this embodiment the plurality of discrete, flat flexibleanchor elements may have any suitable shape. The anchor elements aresufficiently flexible to allow contraction or folding into an anchordelivery catheter and subsequent expansion or unfolding after deploymentfrom the anchor delivery catheter to provide a wider retaining surfaceagainst the tissue. A deploying device may be operatively associatedwith the anchor delivery catheter and operable to extend or deploy theanchor assembly from the anchor delivery catheter. For example, thisdeploying device may further comprise a deploying member, such as aflexible rod or inner deployment catheter, capable of pushing the anchorassembly at least partially out of the lumen of the anchor deliverycatheter.

In another embodiment, a method is provided for anchoring tissue with afirst anchor assembly comprised of a first plurality of discrete, flatflexible anchor elements. The first anchor assembly includes a proximalend portion, a distal end portion and a compressible intermediateportion located between the proximal and distal end portions and movablebetween an elongated configuration and a shortened configuration. Themethod comprises inserting at least one of the anchor elements throughthe tissue and pulling a first flexible tensile member coupled forsliding movement relative to the first plurality of discrete, flatflexible anchor elements. This draws the proximal and distal endportions of the first anchor assembly toward each other and compressesthe intermediate portion into the shortened configuration with theassembly engaged against the tissue. The tissue may comprise the mitralvalve annulus and the first anchor assembly may be engaged on oppositesides of the tissue, such as on opposite sides of the mitral valveannulus. The method may further comprise inserting second and even thirdanchor assemblies through the tissue at spaced apart locations from thefirst anchor assembly and drawing the two or three anchor assembliestoward each other to plicate the tissue whereupon the anchor assembliesare locked relative to each other to lock the plicated condition of thetissue. This procedure may, for example, be repeated any number of timesto plicate the posterior portion of the mitral valve annulus forpurposes of achieving annuloplasty.

In another embodiment, a suture cutter is provided for percutaneouslycutting a suture located within a patient. The suture cutter maycomprise an actuator for manipulation by a medical professional and anintermediate catheter portion operatively coupled to the actuator forinsertion into the vascular system of the patient. A cutting assembly isoperatively coupled to the intermediate catheter portion and theactuator. The cutting assembly includes a blade housing and a blade witha cutting edge mounted for movement in the blade housing. An adjustablysized cutting window is defined between the cutting edge and the bladehousing and the cutting edge cuts a suture received inside of thecutting window as the cutting edge moves in the blade housing to reducethe size of the cutting window. In one embodiment, an anvil may bepositioned on an opposite side of the cutting window from the cuttingedge and the suture may be cut against the anvil. In another embodiment,a blade receiving slot may be located on an opposite side of the cuttingwindow from the cutting edge and the suture may be cut as the blademoves into the blade receiving slot. The blade housing may furthercomprise a first aperture on one side of the blade and a second apertureon an opposite side of the blade such that the suture is adapted to passfrom the first aperture to the second aperture through the cuttingwindow.

In another embodiment, a method of cutting a suture located within apatient is provided and involves positioning a suture cutter within thepatient, with the suture cutter including a blade movable through anadjustably sized cutting window. A suture is directed through thecutting window, such as at a time before the suture cutter is directedinto the patient through the vascular system. The size of the cuttingwindow is reduced by moving the blade towards the suture and the sutureis then cut with the blade, either against an anvil or by directing theblade into a blade receiving space past the suture (e.g., into a slot).The suture cutter may be directed through a catheter leading into thevascular system of the patient. The suture cutter may be used, forexample, to cut the tails from the sutures used during one or more ofthe annuloplasty procedures described herein.

In another embodiment, a plication assistance device is provided and maybe used, for example, to tension and lock the flexible tensile membersdescribed herein. The device comprises a support structure and a firstcarriage fixed to the support structure and configured to hold an outerplication catheter. A second carriage is fixed to the support structureat a location proximal to the first carriage. At least one of the firstor second carriages is slidable along the support structure and capableof being locked in position relative to the support structure. Thesecond or proximal carriage is configured to hold an inner plicationcatheter. A first suture tensioning mechanism is mounted to the supportstructure at a location proximal to the second carriage and a secondsuture tensioning mechanism is mounted to the support structure also ata location proximal to the second carriage. The plication assistancedevice may further comprise a third suture tensioning mechanism mountedto the support structure at a location proximal to the second carriage.The first and second suture tensioning mechanisms may further comprisefirst and second rotatable spools. The first and second carriages mayrespectively include first and second locking devices for securing theouter plication catheter and inner plication catheter thereto. Theplication assistance device may include a suture tension gaugeoperatively connected with the support structure and configured tomeasure tension of a suture being tensioned by at least one of the firstor second suture tensioning mechanisms.

Various additional features, advantages, and aspects of the inventionwill become more readily apparent to those of ordinary skill in the artupon review of the following detailed description of the illustrativeembodiments taken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of a patient with the anatomy of theheart in cross section and a guide catheter introduced through thevascular system into the aorta and heart of the patient.

FIG. 2 is a cross sectional view of the heart from above showing theintroduction of various catheters.

FIG. 3 is a cross sectional view of the heart similar to FIG. 2 andillustrating the further introduction of a guide wire.

FIG. 4 is a partial longitudinal cross sectional view of the heartshowing the positioning of the catheters in the left ventricle andcoronary sinus.

FIG. 5 is a cross sectional view of the heart similar to FIG. 4 , butillustrating the further introduction of a guide wire through the mitralvalve annulus.

FIG. 6 is an enlarged view of the mitral valve in cross section andshowing the introduction of an expandable triple lumen catheter into theleft ventricle.

FIG. 7 is a cross sectional view of the mitral valve similar to FIG. 6and showing the further introduction of the expandable triple lumencatheter.

FIG. 8 is a cross sectional view of the heart similar to FIG. 7 , butillustrating the initial expansion of the triple lumen catheter.

FIG. 9 is an elevational view of the expanding triple lumen catheterrelative to the mitral valve annulus.

FIG. 10 is a view similar to FIG. 9 , but showing the full expansion ofthe triple lumen catheter.

FIG. 11 is an elevational view showing the introduction of an anchordelivery catheter over one of the guide wires.

FIG. 12 is a view similar to FIG. 11 , but showing the initialdeployment of the anchor from the anchor delivery catheter.

FIG. 12A is a view similar to FIG. 12 , but showing a portion of theanchor compressed or shortened on a distal side of the tissue.

FIG. 13 is a view similar to FIG. 12 , but illustrating the fulldeployment of the anchor from the anchor delivery catheter and theanchor delivery catheter being retracted.

FIG. 14 is a view similar to FIG. 13 , but illustrating deployment of asecond anchor from an anchor delivery catheter.

FIG. 15 is a view similar to FIG. 14 , but showing the deployment of athird anchor from an anchor delivery catheter and retraction of theanchor delivery catheter.

FIG. 16 is an elevational view showing the deployment of a suture lockerover the three sutures associated with the respective anchors.

FIGS. 16A, 16B and 16C are enlarged views showing the progressivedeployment and locking of the suture locker onto the three sutures.

FIG. 16D is a longitudinal cross sectional view of the suture lockershowing the locked condition.

FIG. 17 is an elevational view showing retraction of the plicationcatheter and the mitral valve annulus in a plicated condition.

FIG. 18 is a perspective view of a plication assistance device usefulfor tensioning the sutures and deploying the suture locker.

FIGS. 18A and 18B are respective partially cross sectioned views of atension gauge associated with the plication assistance device of FIG. 18with the sections taken lengthwise along the gauge.

FIG. 19 is an elevational view showing the introduction of a suturecutter catheter for cutting the suture material extending from thesuture locker.

FIGS. 20A, 20B and 20C are cross sectional views of the distal endportion of the suture cutter showing the suture cutting operation.

FIG. 21 is a cross sectional view of the locked anchor assembly on theplicated annulus.

FIG. 22 is a cross sectioned view of the mitral valve showing the lockedanchor assembly.

FIG. 23 is a perspective view of a first alternative anchor.

FIG. 24 is a perspective view of a second alternative anchor.

FIG. 25 is an elevational view of a third alternative anchor.

DETAILED DESCRIPTION OF THE ILLUSTRATIVE EMBODIMENTS

Reference will be made to the various figures in describing the methods,devices and systems in various forms useful to the purpose of plicatingtissue, for example, and particularly useful for plicating annulustissue associated with the mitral valve of a patient. It will beappreciated that although specific details of the methods, devices andsystems will be given herein, many different changes, substitutions andadditions may be made to such details by those of ordinary skill whilestill falling within the inventive aspects more generally set forthherein and understood by those of ordinary skill upon review of thepresent disclosure in its entirety. It should be noted that the terms“proximal” and “distal” are used, as conventional in the art, to denotespatial relationship relative to the person using the particular deviceor component. That is, “proximal” refers to a position closer to theuser and “distal” refers to a position farther from the user.

Referring first to FIGS. 1-4 , a guide catheter 50 is illustrated asbeing directed into the vascular system of a patient, such as through anartery in the groin region of the patient, as shown in FIG. 1 . Theguide catheter 50 may be a 12 mm catheter directed through the vascularsystem in any suitable manner. As shown, guide catheter 50 is directedinto the aorta 16, through the aortic valve 18 and into the leftventricle 14 between the pair of cordae tendonae 26, 28 as best shown inFIG. 4 . This guide catheter 50 is then used as a guide sheath or tubefor guiding all of the subsequent catheter devices into the leftventricle 14 for use in a method of plicating the annulus 40 of themitral valve 20. It will be appreciated that other methods of guidancemay be used as alternatives or in a supplemental fashion to the variousmethods disclosed herein. After initial insertion of the guide catheter50, a P2 catheter 52 is inserted to the guide catheter 50. As known inthe art, “P2” refers to the central location of the base of theposterior leaflet 24 along the annulus 40. The P2 catheter 52 may have adeflectable tip to allow more accurate and easier manipulation andlocation of the catheter tip relative to the annulus 40. The cathetertip can include a radiopaque marker 52 a visible under a fluoroscope. Acoronary sinus or CS catheter 56 is directed into the coronary sinus 36via the vascular system of the patient, such as through an entry pointin the jugular vein of the patient and subsequently through the rightatrium 38 as shown best in FIGS. 2 and 3 . The CS catheter 56 isdirected into the coronary sinus 36 as shown in FIG. 3 such that threeradiopaque markers 56 a, 56 b, 56 c on or in the catheter 56 are locatedgenerally at positions approximating P1, P2 and P3 along the mitralvalve annulus 40. In this regard, the coronary sinus 36 runs generallyalong the mitral valve annulus 40 in most patients and thereforeprovides a good location for placement of markers 56 a, 56 b, 56 c. Thedistal tip 52 a of the P2 catheter 52 is aligned at the annulus 40 asshown in FIG. 4 such that it is directed upward at the interior of theleft atrium 12. Radiopaque marker 56 b in the coronary sinus 36 is usedto determine and ensure proper placement of the distal tip 52 a at theP2 location along the annulus 40. Contrast media injections into the LVand/or LA may also be made to confirm positioning under a fluoroscope,for example.

Referring to FIG. 5 , when accurate positioning of the P2 catheter 52has been confirmed using a fluoroscope, for example, a first RF guidewire may be introduced through the P2 catheter. The P2 guide wire mayhave a radio frequency (RF) energy delivery tip 60 a for assisting withpenetration through mitral tissue generally at the annulus 40. For thispurpose, a suitable RF energy device (not shown) may be coupled to guidewire 60, as well as the other RF guide wires disclosed hereinbelow. Thedistal portion of the P2 guide wire 60 then extends into the left atriumand curls back on itself to help prevent tissue damage within the leftatrium 12 as shown best in FIG. 6 .

The method then involves the further introduction of respective P1 andP3 guide wires 62, 64 through the use of a triple lumen catheter 70contained within a sheath 72. Triple lumen catheter 70 and sheath 72 areintroduced into the guide catheter 50 after withdrawal of the P2catheter 52 therefrom. Triple lumen catheter 70 more specificallycomprises a central or first catheter member 74 having a lumen 74 athreaded over the P2 guide wire 60. In addition to this first or P2catheter member 74, triple lumen catheter 70 further comprises secondand third catheter members 76, 78 respectively corresponding generallyto the P1 and P3 locations generally along the posterior mitral annulus40. The second and third catheter members 76, 78 also include respectivelumens 76 a, 78 a containing respective guide wires 62 and 64. It willbe appreciated that other locations along the annulus 40 may be chosenin addition to or instead of those discussed illustratively herein.

As further shown in FIG. 7 , the combined triple lumen catheter 70 andsheath 72 are pushed through the guide catheter 50 and an expandabledistal portion comprised of catheter members 74, 76, 78 is then extendedfrom the sheath 72 in the left ventricle 14 of the patient. The initialpositioning of the P2 guide wire 60 ensures that the middle or P2catheter member 74 will be an accurate reference point at P2. When thesheath 72 reaches the distal location shown in FIGS. 7-9 , the triplelumen catheter 70 is pushed outward from the distal end of the sheath 72and expansion takes place as shown in FIGS. 8 and 9 . As best shown inFIG. 9 , the two outer catheter members 76, 78 (that is, the P1 and P3catheter members) automatically expand outward due to their couplingwith the central or P2 catheter member 74 by way of connecting bars 80,82, 84, 86. These connecting bars may, for example, be formed from thinmetallic plate material such as superelastic material, stainless steel,other metals or combinations of materials. It has been found that a thinplate of Nitinol™ (nickel-titanium) stacked adjacent to a thin plate ofstainless steel works well for each connecting bar 80, 82, 84, 86. TheNitinol exhibits spring characteristics effective for the expansion ofthe two outer catheter members 76, 78 away from the inner or centralcatheter member 74, while the stainless steel plate of each connectingbar provides additional stiffness for support purposes.

Respective connectors 88, 90, 92, 94, 96, 98 couple each connecting bar80, 82, 84, 86 to the respective catheter members 76, 74, 78 as shown inFIG. 9 with a living hinge adjacent each connector 88, 90, 92, 94, 96,98. This illustrative structure therefore essentially forms two four-bartype linkage structures with one being formed by catheter members 74, 76and bars 80, 84 and the other being formed by catheter members 74, 78and bars 82, 86. This expandable structure therefore causes the twoouter catheter members 76, 78 to translate distally and also expandlaterally outward to known positions dictated by the respective lengthsof the bars 80, 82, 84, 86. In this example, the distal end of catheter76 is ultimately positioned approximately at position P1 along themitral annulus 40, while the distal end of catheter member 78 ispositioned approximately at position P3 along the mitral annulus 40. Itwill be appreciated that these positions are representative andillustrative only and that the method may be performed at any otherpositions along the mitral annulus 40 depending on the desires of thesurgeon and needs of the patient, for example.

Catheter members 76, 78 include lumens 76 a, 78 a from which therespective P1 and P3 guide wires 62, 64 may be directed as shown in FIG.10 . Like the P2 guide wire 60, the P1 and P3 guide wires 62, 64 mayinclude RF or radiofrequency energy delivery tips 62 a, 64 a forassisting with penetration through the annulus tissue 40. It will beappreciated that when the “annulus tissue” is referred to herein, thisrefers to tissue generally along the annulus 40 and may, in fact, betissue on the base of the posterior leaflet 24 itself. As shown in FIG.10 , these guide wires 62 a, 64 a may generally align with theradiopaque markers 56 a, 56 c of the CS catheter 56 located in thecoronary sinus 36 (FIG. 3 ). The RF guide wires 62, 64 are insertedthrough the annulus tissue 40 such that distal portions thereof extendinto the left atrium 12 in manners similar to RF guide wire 60 asgenerally shown in FIG. 6 . The triple lumen catheter 70, including thesheath 72, is then removed from the guide catheter 50.

FIGS. 11-15 illustrate the procedure for attaching anchors to theannulus tissue 40. In particular, FIG. 11 shows the initial introductionof a P2 anchor delivery catheter 100 over P2 guide wire 60. As furthershown in FIG. 12 , the distal end low of P2 anchor delivery catheter 100is pushed along RF guide wire 60 until it penetrates through the annulustissue 40. As further shown in FIG. 12 , after the distal end 100 a ispenetrated through the annulus tissue and into the left atrium 12, ananchor assembly 102 is partially deployed as shown. In this embodiment,the anchor assembly 102 comprises a plurality of discrete, flat flexibleanchor elements 104 coupled to a flexible tensile member, for example,in the form of a suture 106. It will be appreciated that in other formsor embodiments of the invention, other anchors (sometimes referred to asfasteners, plicating elements, etc.) may be used instead. As needed, theguide wire 60 may be removed before or after the anchor deploymentprocess. As further shown in FIGS. 12A and 13 , the P2 anchor deliverycatheter 100 is pulled back into the left ventricle 14 and the remainingproximal portion of the anchor assembly 102 is then deployed from thedistal end 100 a such that a portion of the anchor elements 104 arelocated in the left atrium and another portion of the anchor elementsare located in the left ventricle. The anchor elements 104 are coupledto the suture 106, in this example, by threading the suture 106 upwardlythrough the elements 104 and then back downwardly through the anchorelements 104 as shown. A slip knot 108 is then formed, or another typeof lock member is used, so that when a proximal end portion of thesuture 106 is pulled, all of the anchor elements 104 will be drawntogether against opposite sides of the annulus tissue 40 as shown inFIG. 14 . This leaves a long “tail” of the suture 106 outside thepatient's body for subsequent tensioning and plication as will bedescribed below. One or more of the anchor elements 104 may have aradiopaque marker 104 a for better visualization under a suitableviewing device during the procedure. For example, one such marker may belocated on a proximal portion of the anchor 102 and one may be locatedon a distal portion of the anchor 102. Alternatively or in addition, thesuture material or other flexible tension members discussed herein mayhave one or more radiopaque areas for better visualization.

As shown in FIG. 14 , a P1 anchor delivery catheter 110 is threaded overthe P1 guide wire 62 through guide catheter 50 after the P2 anchordelivery catheter 100 has been removed. An anchor assembly 112 againcomprised of discrete, flat flexible anchor elements 114 is deployedthrough a distal end 110 a of the P1 anchor delivery catheter 110 in thesame manner as described above with respect to anchor assembly 102. Likeanchor assembly 102, anchor assembly 112 includes a flexible tensilemember, such as a suture 116, having a slip knot or other lock memberfor drawing the anchor elements 114 together against opposite sides ofthe annulus tissue 40.

Likewise, FIG. 15 illustrates a third or P3 anchor delivery catheter 120used in the same manner as anchor delivery catheters 100, 110 fordeploying a third or P3 anchor assembly 122 comprised of discrete, flatflexible anchor elements 124 coupled by a flexible tensile member, suchas a suture 126, and capable of being drawn together against oppositesides of annulus tissue 40 through the use of a slip knot or other lockmember 128. Anchor delivery catheters 100, 110, 120 may be separatecatheters or may be the same catheter used to separately deliver theanchors or other fasteners or plicating elements. For ease of use,however, separate catheters that have been preloaded with separateanchors may be easiest to use in practice. Suitable pusher rods orelements 125 (FIG. 12 ) may be used to push the anchor assemblies 102,112, 122 from their respective catheters 100, 110, 120. Other deploymentmethods may be used instead. Anchor elements 104, 114, 124 may be formedfrom a material such as a surgical grade fabric material (e.g., apolyester material such as Dacron™) designed to promote tissue ingrowthso that the anchors 102, 112, 122 become essentially encased in tissueover time. As mentioned herein, in various aspects of implementingsystems and methods herein, any suitable anchor may be used. Forexample, other suitable anchors are disclosed in U.S. patent applicationSer. No. 11/174,951, filed Jul. 5, 2005, assigned to the assignee of thepresent invention and the disclosure of which is hereby incorporated byreference herein.

FIGS. 16 and 16A-D generally illustrate a cinching and locking procedurefor plicating the mitral annulus tissue 40. Specifically, this caninvolve the use of an outer plication catheter 130 carrying a suturelocker 132 at its distal end. An inner plication catheter 134 isreceived for sliding movement within the lumen of the outer plicationcatheter 130. The distal end 134 a of the inner plication catheter 134abuts a proximal portion of the suture locker 132. The suture locker 132includes a slidable pin 136 having ends that are received in respectiveslot portions 130 a, 130 b of outer plication catheter 130 at its distalend. More specifically, the pin 136 is initially retained in an angledslot 130 b, and in an identical slot (not shown) on the diametricallyopposite side of the outer plication catheter 134, while the catheterassembly 130, 134 is directed through the guide catheter 50 into theleft ventricle 14 as shown in FIG. 16 . Thus, the inner catheter 134provides an upward force against the suture locker 132 to bias the pinupwardly to the end of the angled slot 130 b as shown in FIG. 16A.

After the respective sutures 106, 116, 126 have been tensioned, thecinching or plicating process and locking process may begin. In thisregard, and as shown in FIG. 16B, the outer plication catheter 130 isinitially moved in a distal direction as shown by the arrow in FIG. 16B,relative to the inner plication catheter 134, to force the pin 136 toride downward in the angled slot 130 b such that it is aligned with thevertical slot 130 a and is pushed upwardly in the slots 138, 140 (FIG.16D). This tightens the pin against the respective sutures 106, 116, 126as the suture locker travels toward the annulus tissue 40. Once thedesired amount of plicated tissue or folds 144 have been formed, theplication catheters 130, 134 may be withdrawn proximally through theguide catheter 50. As shown in FIG. 160 , the suture locker 132 mayinclude a spring-like member 142 for preventing proximal movement of thepin 136 after the desired amount of plication or tightening has beenachieved. For further detail on the suture locker, as well as otherillustrative forms of useful suture lockers, reference is made to U.S.Patent Application Ser. No. 60/803,183, filed on May 25, 2006 andassigned to the assignee of the present invention, and the disclosure ofwhich is hereby fully incorporated by reference herein. It will beunderstood that many types of lockers may be used for locking the anchorassemblies 102, 112, 122, or other fasteners or plicating elements inposition after the desired amount of plication has been achieved. Asshown, anchor elements 114, 124 may also have one or more radiopaquemarkers 114 a, 124 a as discussed above relative to anchor elements 104.Furthermore, the slip knot 108 or other lock member and/or otherportions of the suture material described herein may have one or moreradiopaque markers.

As shown in FIG. 18 , the outer plication catheter 130 includes aproximal hub 146 and the inner plication catheter 134 includes a hub148. FIG. 18 illustrates a plication assistance device 150 that may beused for tensioning the respective sutures 106, 116, 126 and moving thesuture locker 132 as previously described in connection with FIGS. 16,16A-D, and 17. The plication assistance device 150 includes a supportstructure 152 which may take the form of a base plate 152. Base plate152 includes a longitudinally extending slot 152 a. A fixed carriage 154is rigidly affixed to a distal end of the base plate 152 and a slidingcarriage 156 is secured to a more proximal location of base plate 152.More specifically, sliding carriage 156 is affixed by a pin or otherstructure (not shown) so that it may slide along slot 152 a. For thispurpose as well, sliding carriage 156 includes a longitudinallyextending slot 156 a that is parallel to slot 152 a. Slot 156 a receivesa slide lock 158 that may be rotated to respectively lock and unlock thesliding carriage 156 relative to the base plate 152. For this purpose,for example, the slide lock 158 may have a threaded member (not shown)that engages base plate 152. When the slide lock 158 is loosened, thesliding carriage 156 may slide along slot 152 a as the slide lock 158slides along slot 156 a. The slide lock 158 may then be tightened at thedesired position to fix the sliding carriage 156 at a desired locationalong the base plate 152.

The carriages 154, 156 also include respective catheter locks 160, 162that may be rotated to tighten and loosen the connections betweenrespective catheter hubs 146, 148 and carriages 154, 156. A proximal endportion of the base plate 152 includes suture tensioning mechanisms 164,166, 168 for the respective sutures 106, 116, 126. More specifically,these mechanisms include spools 170, 172, 174 for receiving proximal endportions of the respective sutures 106, 116, 126 which may be wrappedand firmly engaged with the spools 170, 172, 174. The suture tensioningmechanisms 164, 166, 168 further comprise rotatable knobs 176, 178, 180connected with respective right angle gear boxes 182, 184, 186 forconverting rotation of the knobs 176, 178, 180 to rotation of the spools170, 172, 174. That is, an output of each gear box 182, 184, 186 iscoupled to a respective one of the spools 170, 172, 174. In this manner,each suture 106, 116, 126 may be separately pulled or tensioned byrotating the corresponding knob 176, 178, 180.

In use, the inner and outer plication catheters 130 and 134 arerespectively secured and locked into the carriages 154 and 156, as shownin FIG. 18 , after the suture locker 132 has been moved approximately tothe position as shown in FIG. 16 . In this position, the suture locker132 is firmly held by the two catheters 130, 134 as previously describedand after the sliding carriage 156 is locked down onto the base plate152 by tightening slide lock 158. At this point, the sutures 106, 116,126 are wrapped around their corresponding spools 170, 172, 174 andtensioned at a suitable minimum force. In the illustrative method, thetension at P1 and P3 (i.e., sutures 116 and 126) may be in the range of2-4 lbs, while the tension at P2 (i.e., suture 106) may be in the rangeof 4-6 lbs. The tension at P1 and P3 is maintained high enough tosustain tissue plication, while the tension of P2 is slightly higher soas to lock or activate the locker 132 after plication occurs. Morespecifically, the higher tension on P2 suture 106 drives the pin 136 inthe locker distally in the slot 138 relative to the body of the locker132. Stated another way, the body of the locker 132 moves slightlyproximally as the pin 136 remains stationary and grips the sutures 106,116, 126.

As best shown in FIGS. 18A and 18B, the plication assistance device 150includes a tension gauge mechanism 188 for allowing the user to measurethe tension of at least one of the sutures 106, 116, 126. Asillustrated, the tension gauge mechanism 188 is being used to measurethe tension of P2 suture 106. More specifically, this illustrativetension gauge mechanism 188 comprises a housing or other support 190having a lever arm 192 pivotally mounted therein by way of a pivot 194.One end of the lever arm 192 includes an element such as a roller 196for engaging the suture 106, while the opposite end includes a pin orother indicator 198 for indicating the level of tension being applied tothe suture 106. A graduated scale 200 is provided in connection with theindicator 198 to indicate the tension being applied to the suture 106.Alternatively, for example, an electronic indicator and digital readoutmay be used. The indicator or pin 198 moves within a slot 202 in thehousing 190 to allow it to be observed by the user. A spring supportmember 203 is also secured rigidly to the housing 190, for example, by apin or fastener 204, or is simply a part of the housing or support 190,and does not allow pivotal movement of the spring support member 203. Anopposite end of the spring support member 203 includes a connectionpoint, which may be a hole 205, while an intermediate location on thelever arm 192 likewise includes a connection point, which may also be ahole 206. A coil spring 207 is connected between these two connectionpoints 205, 206 and applies a force resistive to rotation of the leverarm 192 and upward movement of the indicator 198. Thus, this system,including the spring 207, is designed such that an applied tension inthe direction of the arrow 208 will force the lever arm 192 to rotateclockwise around the pivot 194 (arrow 209) against the force of thespring 207 thereby indicating a measured amount of tension throughupward movement of the indicator or pin 198 along the graduated scale200. The scale 200, for example, may be graduated in any suitable mannerdepending on the needs of the procedure. In the present case, forpurposes of measuring the tension on P2 suture 106, the scale 200 may begraduated to indicate forces between about 4 lbs and about 6 lbs withthe middle of the range being suitable for tensioning the P2 suture 106.

This suture tension provides potential energy that moves the catheters130, 134 relative to each other and locks the suture locker 132 aspreviously described, after the sliding carriage 156 is unlocked byloosening slide lock 158. The plication catheters 130, 132 are thenremoved from the guide catheter 50 leaving the long proximal tails ofthe suture 106, 116, 126 extending out of the patient through the guidecatheter 50.

A suture cutter 210 is threaded along the sutures 106, 116, 126 throughthe guide catheter 50 to the position generally shown in FIG. 19 . Inthis regard, the suture cutter comprises an intermediate catheterportion 212 and a distal end portion comprising a cutting assembly 214.The cutting assembly 214 generally comprises a blade housing 215 and areciprocating guillotine-style blade 216 slidable mounted therein. Theblade 216 includes a cutting edge 216 a as shown best in FIGS. 20A, 20Band 20C. The blade 216 is mounted for sliding, reciprocating movementwithin a slot 218 of blade housing 215. The blade 216 includes anopening 220 through which the sutures 106, 116, 126 extend to cross thepath of the blade 216 within the housing 215. The blade further includesa connecting end 222 coupled to an actuating element 224 which may, forexample, comprise a wire or other member in a lumen 212 a of catheterportion 212. The actuating element 224 may be pulled in the direction ofthe arrow in FIG. 20A to move the blade 216 in a proximal direction. Theuser may accomplish this with a suitable handle or trigger assembly (notshown) coupled to actuator element 224 and located outside the patient.The blade housing 215 includes a first aperture 226 at its distal endand a second aperture 228 along a lateral side thereof opposite to thedistal aperture 226. In this manner, the sutures 106, 116, 126 mayextend into the blade housing 215 through aperture 226, opening 220 ofblade 216 and then through aperture 228 as shown in FIG. 20A. As furthershown in FIGS. 20B and 20C, actuating element 224 may be pulled to movethe blade 216 in a proximal direction such that the cutting edge 216 acrosses edge 218 a with or without a shearing action to cut the sutures106, 116, 126 at points just proximal to suture locker 132 as generallyshown in FIG. 21 . The cutting edge 216 a may have a double bevelconfiguration instead of the single bevel design shown.

The completed annuloplasty or plication procedure is shown in FIG. 22with the posterior leaflet 24 having been moved in an anterior directionto provide better coaptation with the anterior leaflet 22 and generallymoving the posterior wall 42 of the left ventricle 14 in the sameanterior direction.

FIGS. 23-25 illustrate three additional embodiments of anchor assemblieswhich are only representative of the many variations and substitutionsthat may be made with respect to the anchor assemblies described herein.For example, FIG. 23 illustrates an anchor assembly 230 having aplurality of discrete, flat flexible anchor elements 232 coupled along aflexible tensile member such as suture 234. Unlike anchor assemblies102, 112, 122, these anchor elements 232 are coupled to the suture 234such that the suture extends through points separated widthwise alongthe rectangular anchor elements 232 as opposed to lengthwise. Aspreviously discussed, one or more radiopaque markers 232 a may be used.FIG. 24 illustrates an alternative anchor assembly 236 having similardiscrete, flat flexible anchor elements 238 coupled along a flexibletensile member 240 with some anchor elements 238 coupled in a lengthwisefashion and some coupled in a widthwise fashion to the suture 240, asshown. FIG. 25 illustrates another alternative anchor assembly 242comprised of discrete, flat flexible anchor elements 244 coupled forsliding movement along a flexible tensile member such as a suture 246.In this embodiment, the option of having differently sized anchorelements is shown as well as the option of having different spacingbetween coupling points on each anchor element 244 to create differenteffects, such as fabric bunching, etc. It will be appreciated that manyother forms of anchor assemblies utilizing various shapes, sizes andforms of discrete elements coupled for sliding movement along a flexibletensile member may be used with various advantages.

While the present invention has been illustrated by a description ofvarious preferred embodiments and while these embodiments have beendescribed in some detail, it is not the intention of the Applicants torestrict or in any way limit the scope of the appended claims to suchdetail. Additional advantages and modifications will readily appear tothose skilled in the art. The various features discussed herein may beused alone or in any combination depending on the needs and preferencesof the user. This has been a description of illustrative aspects andembodiments the present invention, along with the preferred methods ofpracticing the present invention as currently known. However, theinvention itself should only be defined by the appended claims.

What is claimed is:
 1. A method of cutting a flexible tensile memberlocated within a heart of a patient, the method comprising: introducing,into the patient, a blade that defines an aperture therethrough, aninner perimeter of the blade: enclosing the aperture, and having adistal region and a proximal region, the distal region defining aproximally-facing cutting edge; with the flexible tensile memberthreaded through the aperture, transluminally advancing the bladedistally to the heart by sliding the aperture over and along theflexible tensile member with the cutting edge facing the flexibletensile member; and subsequently, cutting the flexible tensile member bypulling the blade proximally, such that the cutting edge movesproximally through the flexible tensile member.
 2. The method of claim1, wherein transluminally advancing the blade distally to the heartcomprises advancing the blade through a catheter.
 3. The method of claim1, wherein cutting the flexible tensile member comprises cutting theflexible tensile member against an anvil.
 4. The method according toclaim 1, wherein the blade is a component of a suture cutter thatincludes a housing, and wherein introducing the blade into the patientcomprises introducing the blade into the patient while the blade isdisposed within the housing.
 5. The method according to claim 4, whereincutting the flexible tensile member by pulling the blade proximallycomprises cutting the flexible tensile member by pulling the bladeproximally with respect to the housing.
 6. The method according to claim4, wherein the housing defines an internal slot, and whereintransluminally advancing the blade distally to the heart by sliding theaperture over and along the flexible tensile member comprisestransluminally advancing the blade distally to the heart by sliding theaperture over and along the flexible tensile member while the cuttingedge is concealed within the internal slot.
 7. The method according toclaim 6, wherein cutting the flexible tensile member by pulling theblade proximally comprises cutting the flexible tensile member bypulling the blade proximally such that the cutting edge moves proximallywithin the internal slot towards the flexible tensile member.
 8. Themethod according to claim 7, wherein the housing defines ablade-restraining floor at a proximal end of the internal slot,configured to limit proximal movement of the blade within the internalslot, and wherein cutting the flexible tensile member by pulling theblade proximally comprises cutting the flexible tensile member bypulling the blade proximally until at least a part of the blade abutsthe blade-restraining floor.
 9. The method according to claim 4,wherein: the housing defines a longitudinal axis, the blade is flat,thereby defining a blade plane, the blade extends, within the housing,along the longitudinal axis, and cutting the flexible tensile member bypulling the blade proximally comprises cutting the flexible tensilemember by pulling the blade proximally such that the blade moves axiallywithin the housing.
 10. The method according to claim 9, wherein thecutting edge is (i) on the blade plane, and (ii) oblique with respect tothe longitudinal axis, and wherein cutting the flexible tensile memberby pulling the blade proximally comprises cutting the flexible tensilemember by pulling the blade proximally such that the blade moves axiallywithin the blade plane.
 11. The method according to claim 9, wherein:the housing defines a distal suture port at a first side of the bladeplane, and a proximal suture port at a second side of the blade plane,the second side being opposite to the first side, the aperture isdisposed on the blade plane, and transluminally advancing the bladedistally to the heart by sliding the aperture over and along theflexible tensile member comprises transluminally advancing the bladedistally to the heart by sliding the aperture over and along theflexible tensile member with the flexible tensile member disposedthrough (i) the distal suture port, (ii) the aperture of the blade, and(iii) the proximal suture port.
 12. The method according to claim 11,wherein cutting the flexible tensile member comprises cutting theflexible tensile member in the blade plane.
 13. The method according toclaim 11, wherein: the distal suture port is disposed at a distal end ofthe housing, facing distally, the proximal suture port is disposed at alateral wall of the housing, and transluminally advancing the bladedistally to the heart by sliding the aperture over and along theflexible tensile member, with the flexible tensile member disposedthrough the aperture comprises transluminally advancing the bladedistally to the heart by sliding the aperture over and along theflexible tensile member such that a portion of the flexible tensilemember extends: into the distal suture port, substantially parallel tothe blade plane, within the suture cutter, oblique to the blade plane,through the aperture and toward the proximal suture port, and out of theproximal suture port, and proximally alongside the suture cutter. 14.The method according to claim 1, wherein the flexible tensile member isa first flexible tensile member of multiple flexible tensile members,and wherein: transluminally advancing the blade distally to the heart bysliding the aperture over and along the flexible tensile membercomprises transluminally advancing the blade distally to the heart bysliding the aperture over and along the multiple flexible tensilemembers, and cutting the flexible tensile member by pulling the bladeproximally comprises cutting the multiple flexible tensile members bypulling the blade proximally, such that the cutting edge movesproximally through the multiple flexible tensile members.
 15. The methodaccording to claim 1, wherein the blade is planar, and whereinintroducing the blade into the patient comprises introducing, into thepatient, the blade that is planar.
 16. The method according to claim 1,wherein the blade is a guillotine-style blade, and wherein introducingthe blade into the patient comprises introducing the guillotine-styleblade into the patient.
 17. The method according to claim 1, wherein theblade is coupled to an actuating element, and wherein cutting theflexible tensile member by pulling the blade proximally comprisesactuating the actuating element to pull the blade proximally, therebycutting the flexible tensile member.
 18. A method of cutting a flexibletensile member located within a patient, the method comprising:introducing, into the patient, a blade that: defines an aperturetherethrough, an inner perimeter of the blade delineating the apertureand defining a proximally-facing cutting edge, and is disposed within ahousing that defines (i) an internal slot, and (ii) a blade-restrainingfloor at a proximal end of the internal slot, configured to limitproximal movement of the blade within the internal slot; while thecutting edge is concealed within the internal slot, transluminallyadvancing the blade over and along the flexible tensile member, with theflexible tensile member disposed through the aperture; and cutting theflexible tensile member by pulling the blade proximally such that thecutting edge moves proximally within the internal slot towards andthrough the flexible tensile member, until at least a part of the bladeabuts the blade-restraining floor.
 19. The method according to claim 18,wherein the inner perimeter has a distal region and a proximal region,the distal region defining the cutting edge, and wherein transluminallyadvancing the blade comprises transluminally advancing the blade overand along the flexible tensile member with the cutting edge facing theflexible tensile member.
 20. The method according to claim 18, whereinthe flexible tensile member is a first flexible tensile member ofmultiple flexible tensile members, and wherein: transluminally advancingthe blade over and along the flexible tensile member comprisestransluminally advancing the blade over and along the multiple flexibletensile members, and cutting the flexible tensile member by pulling theblade proximally comprises cutting the multiple flexible tensile membersby pulling the blade proximally, such that the cutting edge movesproximally through the multiple flexible tensile members.
 21. The methodaccording to claim 18, wherein the blade is planar, and whereinintroducing the blade into the patient comprises introducing, into thepatient, the blade that is planar.
 22. The method according to claim 18,wherein the blade is a guillotine-style blade, and wherein introducingthe blade into the patient comprises introducing the guillotine-styleblade into the patient.
 23. The method according to claim 18, wherein:the housing defines a longitudinal axis, the blade is flat, therebydefining a blade plane, the blade extends, within the housing, along thelongitudinal axis, and cutting the flexible tensile member by pullingthe blade proximally comprises cutting the flexible tensile member bypulling the blade proximally such that the blade moves axially withinthe housing.
 24. The method according to claim 23, wherein the cuttingedge is (i) on the blade plane, and (ii) oblique with respect to thelongitudinal axis, and wherein cutting the flexible tensile member bypulling the blade proximally comprises cutting the flexible tensilemember by pulling the blade proximally such that the blade moves axiallywithin the blade plane.
 25. The method according to claim 23, wherein:the housing defines a distal suture port at a first side of the bladeplane, and a proximal suture port at a second side of the blade plane,the second side being opposite to the first side, the aperture isdisposed on the blade plane, and transluminally advancing the blade overand along the flexible tensile member comprises transluminally advancingthe blade over and along the flexible tensile member with the flexibletensile member disposed through (i) the distal suture port, (ii) theaperture of the blade, and (iii) the proximal suture port.
 26. Themethod according to claim 25, wherein cutting the flexible tensilemember comprises cutting the flexible tensile member in the blade plane.27. The method according to claim 25, wherein: the distal suture port isdisposed at a distal end of the housing, facing distally, the proximalsuture port is disposed at a lateral wall of the housing, andtransluminally advancing the blade over and along the flexible tensilemember, with the flexible tensile member disposed through the aperturecomprises transluminally advancing the blade over and along the flexibletensile member such that a portion of the flexible tensile memberextends: into the distal suture port, substantially parallel to theblade plane, within the suture cutter, oblique to the blade plane,through the aperture and toward the proximal suture port, and out of theproximal suture port, and proximally alongside the suture cutter. 28.The method according to claim 18, wherein the blade is coupled to anactuating element, and wherein cutting the flexible tensile member bypulling the blade proximally comprises actuating the actuating elementto pull the blade proximally, thereby cutting the flexible tensilemember.
 29. A method of cutting a flexible tensile member located withina heart of a patient, the method comprising: introducing, into thepatient, a planar blade that defines an aperture therethrough, an innerperimeter of the planar blade enclosing the aperture and defining aproximally-facing cutting edge; with the flexible tensile memberthreaded through the aperture, transluminally advancing the planar bladedistally to the heart by sliding the aperture over and along theflexible tensile member; and subsequently, cutting the flexible tensilemember by pulling the planar blade proximally, such that the cuttingedge moves proximally through the flexible tensile member.
 30. Themethod of claim 29, wherein transluminally advancing the planar bladedistally to the heart comprises advancing the planar blade through acatheter.
 31. The method of claim 29, wherein cutting the flexibletensile member comprises cutting the flexible tensile member against ananvil.
 32. The method according to claim 29, wherein the inner perimeterhas a distal region and a proximal region, the distal region definingthe cutting edge, and wherein transluminally advancing the planar bladecomprises transluminally advancing the planar blade over and along theflexible tensile member with the cutting edge facing the flexibletensile member.
 33. The method according to claim 29, wherein the planarblade is a component of a suture cutter that includes a housing, andwherein introducing the planar blade into the patient comprisesintroducing the planar blade into the patient while the planar blade isdisposed within the housing.
 34. The method according to claim 33,wherein cutting the flexible tensile member by pulling the planar bladeproximally comprises cutting the flexible tensile member by pulling theplanar blade proximally with respect to the housing.
 35. The methodaccording to claim 33, wherein the housing defines an internal slot, andwherein transluminally advancing the planar blade distally to the heartby sliding the aperture over and along the flexible tensile membercomprises transluminally advancing the planar blade distally to theheart by sliding the aperture over and along the flexible tensile memberwhile the cutting edge is concealed within the internal slot.
 36. Themethod according to claim 35, wherein cutting the flexible tensilemember by pulling the planar blade proximally comprises cutting theflexible tensile member by pulling the planar blade proximally such thatthe cutting edge moves proximally within the internal slot towards theflexible tensile member.
 37. The method according to claim 36, whereinthe housing defines a blade-restraining floor at a proximal end of theinternal slot, configured to limit proximal movement of the planar bladewithin the internal slot, and wherein cutting the flexible tensilemember by pulling the planar blade proximally comprises cutting theflexible tensile member by pulling the planar blade proximally until atleast a part of the planar blade abuts the planar blade-restrainingfloor.
 38. The method according to claim 29, wherein the flexibletensile member is a first flexible tensile member of multiple flexibletensile members, and wherein: transluminally advancing the planar bladedistally to the heart by sliding the aperture over and along theflexible tensile member comprises transluminally advancing the planarblade distally to the heart by sliding the aperture over and along themultiple flexible tensile members, and cutting the flexible tensilemember by pulling the planar blade proximally comprises cutting themultiple flexible tensile members by pulling the planar bladeproximally, such that the cutting edge moves proximally through themultiple flexible tensile members.
 39. The method according to claim 29,wherein the planar blade is a guillotine-style blade, and whereinintroducing the planar blade into the patient comprises introducing theguillotine-style blade into the patient.
 40. The method according toclaim 29, wherein the planar blade is coupled to an actuating element,and wherein cutting the flexible tensile member by pulling the planarblade proximally comprises actuating the actuating element to pull theplanar blade proximally, thereby cutting the flexible tensile member.41. A method of cutting a flexible tensile member located within a heartof a patient, the method comprising: introducing, into the patient, asuture cutter that includes a housing that defines a longitudinal axisand that houses a flat blade that (i) defines a blade plane, the bladeextending, within the housing, along the longitudinal axis, and (ii)defines an aperture therethrough, an inner perimeter of the bladeenclosing the aperture and defining a proximally-facing cutting edge;with the flexible tensile member threaded through the aperture,transluminally advancing the blade distally to the heart by sliding theaperture over and along the flexible tensile member; and subsequently,cutting the flexible tensile member by pulling the blade proximally suchthat the blade moves axially within the housing and the cutting edgemoves proximally through the flexible tensile member.
 42. The methodaccording to claim 41, wherein the cutting edge is (i) on the bladeplane, and (ii) oblique with respect to the longitudinal axis, andwherein cutting the flexible tensile member by pulling the bladeproximally comprises cutting the flexible tensile member by pulling theblade proximally such that the blade moves axially within the bladeplane.
 43. The method according to claim 41, wherein: the housingdefines a distal suture port at a first side of the blade plane, and aproximal suture port at a second side of the blade plane, the secondside being opposite to the first side, the aperture is disposed on theblade plane, and transluminally advancing the blade distally to theheart by sliding the aperture over and along the flexible tensile membercomprises transluminally advancing the blade distally to the heart bysliding the aperture over and along the flexible tensile member with theflexible tensile member disposed through (i) the distal suture port,(ii) the aperture of the blade, and (iii) the proximal suture port. 44.The method according to claim 43, wherein cutting the flexible tensilemember comprises cutting the flexible tensile member in the blade plane.45. The method according to claim 43, wherein: the distal suture port isdisposed at a distal end of the housing, facing distally, the proximalsuture port is disposed at a lateral wall of the housing, andtransluminally advancing the blade distally to the heart by sliding theaperture over and along the flexible tensile member, with the flexibletensile member disposed through the aperture comprises transluminallyadvancing the blade distally to the heart by sliding the aperture overand along the flexible tensile member such that a portion of theflexible tensile member extends: into the distal suture port,substantially parallel to the blade plane, within the suture cutter,oblique to the blade plane, through the aperture and toward the proximalsuture port, and out of the proximal suture port, and proximallyalongside the suture cutter.